NCT01502371

A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 583 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg	MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks
DRUG	Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg	MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks
DRUG	Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg	MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks
DRUG	Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg	MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
DRUG	Placebo Metered Dose Inhaler (MDI)	Placebo MDI, 2 puffs BID for 12 weeks
DRUG	Placebo Dry Powder Inhaler (DPI)	Placebo DPI, 1 puff QD for 12 weeks

Timeline

• Start date: 2012-01-25
• Primary completion: 2015-01-29
• Completion: 2015-01-29
• First posted: 2011-12-30
• Last updated: 2024-06-17
• Results posted: 2015-10-06